Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

89 results found

Title
Status

 

YmAbs201 - A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Open

YmAbs201 - A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

Go to Health Care Provider version

DiagnosisNeuroblastomaStudy StatusOpen
PhaseII
AgeChild, Adult, Older Adult - (1 Year and older)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment Administrationnaxitamab (intravenous); GM-CSF (sub-cutaneous)
Last Posted Update2024-01-19
ClinicalTrials.gov #NCT03363373
International Sponsor
Y-mAbs Therapeutics
Principal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This is a study of naxitamab, also known as hu3F8, a humanised antibody targeting GD2 in children and adults diagnosed with high-risk neuroblastoma. GD2 is a marker present at the surface of the neuroblastoma cells; therefore the naxitamab can target the neuroblastoma cells and stimulate the immune system to kill them.

Patients with with primary refractory disease (disease that has never improved with previous treatment), or patients that have had a relapse but incomplete response of the disease in bone and/or bone marrow from salvage treatment will be considered for this study.

Granulocyte-macrophage colony stimulating factor (GM-CSF) will be given along naxitamab.

Inclusion Criteria
  • Diagnosis of high-risk neuroblastoma with disease in bone and/or bone marrow.
  • High-risk neuroblastoma patients with either primary refractory disease or incomplete response to salvage treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

Closed to enrollment

STEP-RB - Phase I Sustained-Release Topotecan Episcleral Plaque (Chemoplaque) for Retinoblastoma

Go to Health Care Provider version

DiagnosisRetinoblastoma Study StatusClosed to enrollment
PhaseI
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationTopotecan - administered using an episcleral plaque (chemoplaque), an implant which contains topotecan (drug). The implant is attached to the outside of the eye and delivers topotecan directly into the eye.
Last Posted Update2024-01-09
ClinicalTrials.gov #NCT04428879
International Sponsor
The Hospital for Sick Children
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well a chemoplaque with topotecan (a medication attached to the outside of the eye) works in treating patients with retinoblastoma. This plaque has to be installed and removed under general anesthesia by the ophthalmology team. It delivers the chemotherapy inside the eye.

Inclusion Criteria
  • Age up to 18 years
  • Retinoblastoma in at least one eye
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Suspended

ACT15378 ISAKIDS - Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

Go to Health Care Provider version

DiagnosisAcute Lymphoblastic Leukemia, Acute Myeloid LeukemiaStudy StatusSuspended
PhaseII
AgeChild - (up to 17 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIntravenous for isatuximab; Other drugs as usually administered for leukemia therapy
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT03860844
International Sponsor
Sanofi
Principal Investigators for Canadian Sites
Montreal Children’s Hospital - Dr. Surabhi Rawal
BC Children's Hospital - Dr. Amanda Li
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

This is study of a new medication called isatuximab (antibody against a marker called CD38) in combination with standard chemotherapy for children with acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment. The main objective of this study is to understand the anti-leukemia effect of this medication. 

Inclusion Criteria
  • Age between 28 days to less than 18 years of age
  • Acute lymphoblastic leukemia or acute myeloid leukemia that has relapsed or is refractory to treatment
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

OZM-063 - A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma (LGG)

Closed to enrollment

OZM-063 - A Phase II, Open-Labeled, Multi-Center, Randomized Controlled Trial of Vinblastine +/- Bevacizumab for the Treatment of Chemotherapy-Naïve Children With Unresectable or Progressive Low Grade Glioma (LGG)

Go to Health Care Provider version

DiagnosisLow Grade GliomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (6 Months to 18 Years)RandomisationYES
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment Administrationintravenous
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT02840409
International Sponsor
The Hospital for Sick Children / Hoffmann-La Roche
Principal Investigators for Canadian Sites
Montreal Children’s Hospital – Dr. Geneviève Legault
The Hospital for Sick Children – Dr. Uri Tabori
Alberta Children’s – Dr. Lucie Lafay-Cousin
BC Children’s Hospital – Dr. Juliette Hukin
CHU Ste-Justine – Dr. Yvan Samson
Stollery Children’s Hospital – Dr. Bev Wilson
CHU de Quebec - Dr. Valerie Larouche
CancerCare Manitoba - Dr. Issai Vanan
Children’s Hospital of Eastern Ontario (CHEO) - Dr. Donna L. Johnston
Hamilton Health Sciences Centre - Dr. Uma Athale
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Raoul Santiago
 
Social worker/patient navigator contact
Isabelle Audet
 
Clinical research contact
Barbara Desbiens
 

 

Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 

 

 

Study Description

This study is trying to determine the benefit of adding bevacizumab (an intravenous drug) to chemotherapy treatment with vinblastine, in children and adolescents with low grade gliomas.

Participants in this trial will be randomised (randomly assigned) into one of two treatment arms.

  • Arm A will include 68 weeks (16 months) of single agent Vinblastine given once weekly intravenously.
  • Arm B will include 68 weeks (16 months) of Vinblastine given weekly intravenously with the addition of 12 doses of bevacizumab given every two weeks intravenously for the initial 24 weeks (6 months).
Inclusion Criteria
  • Children and adolescents aged 6 months to < 18 years
  • Low grade glioma 
  • The tumour must have grown back after surgery with clear imaging or clinical signs, or
  • The tumour was partially removed with surgery and there is a necessity to begin treatment because of a risk of neurological impairment with progression.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

 

 

LOXO-TRK-15003 (SCOUT) - A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors

Closed to enrollment

LOXO-TRK-15003 (SCOUT) - A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors

Go to Health Care Provider version

DiagnosisSolid tumors with NTRK fusion, Brain Tumors with NTRK, Fusion infantile fibrosarcoma, congenital mesoblastic nephroma, secretory breast cancer Study StatusClosed to enrollment
PhaseI/II
AgeChild, Adult - (up to 21 Years)RandomisationNO
Line of treatmentFirst line treatment, Disease relapse or progression
Routes of Treatment AdministrationOral (capsule or in liquid form)
Last Posted Update2024-01-08
ClinicalTrials.gov #NCT02637687
International Sponsor
Bayer
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
CHU Ste Justine - Dr. Sébastien Perreault
BC Children's Hospital - Dr. Rebecca Deyell
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

The purpose of this study is to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). NTRK gene changes lead to abnormal proteins called TRK fusion proteins, which may cause cancer cells to grow. Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectinib.

Inclusion Criteria
  • Children from birth through 21 years of age
  • Patient with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists
  • Patient must have a malignancy with a documented NTRK gene fusion.
  • Patient with a infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer Patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer may enroll into this cohort with documentation of an ETV6 rearrangement or a documented NTRK fusion by next generation sequencing.

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

Publications

Bielack SS, Cox MC, Nathrath M, Apel K, Blattmann C, Holl T, Jenewein R, Klenk U, Klothaki P, Müller-Abt P, Ortega-Lawerenz S, Reynolds M, Scheer M, Simon-Klingenstein K, Stegmaier S, Tupper R, Vokuhl C, von Kalle T. Rapid, complete and sustained tumour response to the TRK inhibitor larotrectinib in an infant with recurrent, chemotherapy-refractory infantile fibrosarcoma carrying the characteristic ETV6-NTRK3 gene fusion. Ann Oncol. 2019 Nov;30 Suppl 8:viii31-viii35. doi: 10.1093/annonc/mdz382. Epub 2019 Dec 24.

Hong DS, DuBois SG, Kummar S, Farago AF, Albert CM, Rohrberg KS, van Tilburg CM, Nagasubramanian R, Berlin JD, Federman N, Mascarenhas L, Geoerger B, Dowlati A, Pappo AS, Bielack S, Doz F, McDermott R, Patel JD, Schilder RJ, Tahara M, Pfister SM, Witt O, Ladanyi M, Rudzinski ER, Nanda S, Childs BH, Laetsch TW, Hyman DM, Drilon A. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020 Apr;21(4):531-540. doi: 10.1016/S1470-2045(19)30856-3. Epub 2020 Feb 24.

Bielack SS, Cox MC, Nathrath M, Apel K, Blattmann C, Holl T, Jenewein R, Klenk U, Klothaki P, Müller-Abt P, Ortega-Lawerenz S, Reynolds M, Scheer M, Simon-Klingenstein K, Stegmaier S, Tupper R, Vokuhl C, von Kalle T. Rapid, complete and sustained tumour response to the TRK inhibitor larotrectinib in an infant with recurrent, chemotherapy-refractory infantile fibrosarcoma carrying the characteristic ETV6-NTRK3 gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii31-viii35. doi: 10.1093/annonc/mdz382.

DuBois SG, Laetsch TW, Federman N, Turpin BK, Albert CM, Nagasubramanian R, Anderson ME, Davis JL, Qamoos HE, Reynolds ME, Cruickshank S, Cox MC, Hawkins DS, Mascarenhas L, Pappo AS. The use of neoadjuvant larotrectinib in the management of children with locally advanced TRK fusion sarcomas. Cancer. 2018 Nov 1;124(21):4241-4247. doi: 10.1002/cncr.31701. Epub 2018 Sep 11.

Laetsch TW, DuBois SG, Mascarenhas L, Turpin B, Federman N, Albert CM, Nagasubramanian R, Davis JL, Rudzinski E, Feraco AM, Tuch BB, Ebata KT, Reynolds M, Smith S, Cruickshank S, Cox MC, Pappo AS, Hawkins DS. Larotrectinib for paediatric solid tumours harbouring NTRK gene fusions: phase 1 results from a multicentre, open-label, phase 1/2 study. Lancet Oncol. 2018 May;19(5):705-714. doi: 10.1016/S1470-2045(18)30119-0. Epub 2018 Mar 29. Erratum in: Lancet Oncol. 2018 May;19(5):e229.

Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.

LOXO-RET-18036 (LOXO 292) - A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Open

LOXO-RET-18036 (LOXO 292) - A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Go to Health Care Provider version

DiagnosisSolid or brain tumour with a change in the RET geneStudy StatusOpen
PhaseI/II
AgeChild, Adult - (6 Months to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationSelpercatinib is taken by mouth (capsules or oral suspension) Participants <18 years of age may be offered to try a tablet formulation of selpercatinib.
Last Posted Update2024-01-03
ClinicalTrials.gov #NCT03899792
International Sponsor
Loxo Oncology, Inc.
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel Morgenstern
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

This clinical trial studies the side effects and how well selpercatinib (a medication taken by mouth) works in treating patients with solid tumors and brain tumours with a change in a gene called RET. 

Selpercatinib may stop the growth of cancer cells with RET gene changes by blocking the RET enzymes needed for cell growth.

Inclusion Criteria
  • Age between 6 months and 21 years
  • Solid tumors and brain tumours with a change in a gene called RET
  • Cancer that has come back (relapse) or is not improving despite treatment (progression)
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

ACNS1422 - A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Open

ACNS1422 - A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients

Go to Health Care Provider version

DiagnosisMedulloblastomaStudy StatusOpen
PhaseII
Age3 Years to 21 YearsRandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationChemotherapy: Cisplatin (Given IV), Cyclophosphamide (Given IV), Lomustine (Given PO), Vincristine Sulfate (Given IV or via minibag) Radiation: Radiation Therapy
Last Posted Update2023-11-09
ClinicalTrials.gov #NCT02724579
International Sponsor
Children's Oncology Group
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Victor Lewis
BC Children's Hospital - Dr. David Dix
CancerCare Manitoba - Dr. Ashley Chopek
Janeway Child Health Centre - Dr. Lisa Goodyear
IWK Health Centre - Dr. Craig Erker
McMaster Children's Hospital at Hamilton Health Sciences - Dr. Uma Athale
Western Children's Hospital - Dr. Shayna Zelcer
Children's Hospital of Eastern Ontario - Dr. Donna Johnston
Hospital for Sick Children - Dr. Vijay Ramaswamy
Montreal Children's Hospital - Dr. Genevieve Legault
Saskatoon Cancer Centre - Dr. Kathleen Felton
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Dr. Magimairajan Vanan
Social worker/patient navigator contact
Rhéanne Bisson
 
Clinical research contact
Rebekah Hiebert
Megan Ridler
Kathy Hjalmarsson

 

 

Medical contact
Dr. Paul Moorehead
 
Social worker/patient navigator contact
Stephanie Eason
 
Clinical research contact
Bev Mitchell
 
Medical contact
Dr. Craig Erker
Dr. Conrad Fernandez 
Dr. Ketan Kulkarni 
 
Social worker/patient navigator contact
Rhonda Brophy
 
Clinical research contact
Tina Bocking
 
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Alexandra Zorzi
Dr. Shayna Zelcer
 
Social worker/patient navigator contact
Cindy Milne Wren
Jessica Mackenzie Harris
 
Clinical research contact
Mariam Mikhail
Medical contact
Dr. Donna Johnston
Dr. Lesleigh Abbott
Dr. Doaa Abdel Fattah
 
Social worker/patient navigator contact
Sherley Telisma
 
Clinical research contact
Carol Duchenne
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact
Dr. Chris Mpofu

 

 

Social worker/patient navigator contact
Jillian Galambos
La Rae Beebe

 

Clinical research contact
Susan Kaban

 

 

 

Study Description

This phase 2 trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT-driven medulloblastoma.

(via: https://childrensoncologygroup.org/acns1422)

Inclusion Criteria
  • Patients are between 3 years to 21 years old
  • Patient is newly diagnosed with average-risk medulloblastoma  in the WNT subgroup by institutional diagnosis
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

AALL1521 - A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia

Closed to enrollment

AALL1521 - A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia

Go to Health Care Provider version

DiagnosisALL, B-cell acute lymphoblastic leukemiaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (2 years to 21 years)RandomisationN/A
Line of treatmentFirst line treatment
Routes of Treatment AdministrationRuxolitinib - oral; Other drugs are given as usually administered for leukemia therapy
Last Posted Update2023-11-09
ClinicalTrials.gov #NCT02723994
International Sponsor
Incyte Corporation
Principal Investigators for Canadian Sites
BC Children's Hospital – Dr. David Dix
Montreal Children's Hospital – Dr. Sharon Abish
Alberta Children's Hospital – Dr. Victor Lewis
The Hospital for Sick Children – Dr. Ute Bartels
Hamilton Health Sciences Centre, McMaster University - Dr. Carol Portwine
CHU Ste Justine - Dr. Thai Tran


Centres
Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact
Dr. Carol Portwine
 
Social worker/patient navigator contact
Jane Cassano 
 
Clinical research contact
Sabrina Millson
 
 
Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

Philadelphia-like leukemia has specific genetic changes. This study is to assess the dose and effectiveness of an oral medication called ruxolitinib that targets Philadelphia-like leukemia cells. It blocks a protein called JAK. The medication is given in addition to standard therapy for the leukemia. 

Based on the leukemia genetics and initial response to treatment, patients are divided into 4 groups. 

 

Inclusion Criteria
  • Patients between 1 and 21 years of age
  • New diagnosis of Philadelphia-like, high-risk B-cell acute lymphoblastic leukemia
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team